AgaMatrix WaveSense Keynote User manual

− Remove the Lancet: When you have nished
testing, pull o the cap from the lancing device. Replace
the lancet top. Extract the lancet from the lancet holder
cup by pulling on the plastic collar of the lancet (near
the middle of the lancet). Replace the lancing device cap
until it snaps or clicks into place.
Discard the used WaveSense
KeyNote Test Strip and Lancet
properly.
WARNING: The lancing
device should only be used
by one patient. Do not
re-use lancets.
− Remove Test Strip from Blood Sample When
You Hear The Beep: Your meter will beep once
indicating that you should
remove the tip of the
WaveSense KeyNote Test Strip
from the blood sample.
The moving dot bar indicates
that your blood glucose test is
in progress.
Your test is completed when your
blood glucose test result with time
and date is shown on the display. If
the volume is enabled in SET Options,
you will hear a beep. Your test result is
now stored in the memory.
[5] Final Steps
− Remove the Test Strip:
Remove the used WaveSense
KeyNote Test Strip. The WaveSense
KeyNote Meter will automatically
deactivate.
of the WaveSense KeyNote Test Strip will turn red.
IMPORTANT: [1] Remove the test
strip from the blood sample as soon as
you hear the beep. [2] Do not press
the WaveSense KeyNote Test Strip
against the test site. [3] Do not scrape
blood onto the WaveSense KeyNote
Test Strip. [4] Do not apply blood to
the top side of the WaveSense KeyNote Test Strip. [5]
Do not apply blood to the WaveSense KeyNote Test
Strip when the test strip is out of the meter. [6] Do
not put blood or foreign objects into the WaveSense
KeyNote strip port. [7] Do not apply more blood after
beep. [8] Carefully read the test results on the screen
before making any treatment decisions.
On the display, blood drop symbols appear on the
test strip symbol to indicate that blood is lling the
WaveSense KeyNote Test Strip.
− Express Blood Drop: Wipe
away the rst blood drop that
appears using a clean tissue or
paper towel. Squeeze from the
base of your nger up towards
the tip, until a second small blood
drop forms. Do not squeeze directly
around the lanced area.
[4] Applying Blood Sample
CAUTION: Be sure not to press the RIGHT or LEFT
arrow buttons while applying blood. You might
accidentally change the calibration code number.
− Bring Test Strip to Blood Sample: The meter now
displays the blood drop and test strip symbols. This means
your WaveSense KeyNote System is now ready for you to
apply blood. Immediately bring
the WaveSense KeyNote Test Strip
to the blood sample. Thetest strip
llsfrom the tip. Do not try to
smear blood on the top surface.
The WaveSense KeyNote Test Strip
acts like a sponge and draws the
blood into the test strip through the
sample area. The visual ll window
number as printed on the test strip vial. The meter now
displays the blood drop and
test strip symbols.
The WaveSense KeyNote
System is now ready for you to apply blood.
Note: You can still change the code number as long as
you have not applied blood to the WaveSense KeyNote
Test Strip by pressing the LEFT and RIGHT arrow buttons.
[3] Lancing
− Lance Test Site: To ensure accurate results, wash
hands with warm, soapy water and dry before every
glucose test. For details on possible test sites, refer
to section 1, “Important Information About Your
WaveSense KeyNote System.”
For instructions on how to test on your palm or
forearm, please refer to section 7, “Testing On Your
Palm or Forearm.”
Note: Keep your hand warm or gently massage the site
you are lancing to stimulate blood ow.
Press the lancing device
against the site to be
lanced. Press the release
button.
CAUTION: To ensure accurate results, wash your
hands with warm, soapy water and dry before
every test. Make sure there is no grease, oil or
lotion on the test site. Use lancets only once.
Do not use any lancet that has been used by
another person. Interfering substances (see test
strip insert sheet for interfering substances) on
unwashed hands may lead to inaccurate results.
[1] Preparing the WaveSense Lancing Device:
Use the gray cap for testing on a ngertip and the clear
cap for testing on the palm (at the base of the thumb)
or forearm.
– Remove Lancing
Device Cap: Pull the cap
o the lancing device.
– Insert New Lancet:
Insert a new WaveSense
Lancet rmly into the
lancet holder cup. Pushing
the lancet into the lancet
holder cup may cock the
device; this is OK.
On the WaveSense KeyNote Meter display, droplet symbols
appear on the test strip symbol to indicate that the control
solution is lling the WaveSense KeyNote Test Strip.
Your meter will beep once indicating that you should
remove the tip of the WaveSense KeyNote Test Strip from
the control solution sample.
[4] Viewing Control Solution Test Result: The
result will appear on the display screen and, if the volume
is enabled, your meter will beep once. The word “control”
will also appear on the display screen.
Compare the result of your
control solution test to
the range printed on the
WaveSense KeyNote Test
Strip vial label for the control
solution level (normal or high)
that you used. Your control solution result
should fall within this range. The control
solution test result is stored in memory.
test strip vial, press the LEFT or RIGHT buttons until the
meter displays the same code number as printed on the
test strip vial.
[3] Applying Control Solution: Shake the control
solution bottle. Discard the rst drop of control solution
and wipe the bottle tip clean using
a clean tissue or paper towel.
Dispense a second drop onto a
clean surface, such as an unused
resealable plastic bag. Bring the
tip of the test strip to the control solution sample. The
WaveSense KeyNote System will automatically detect if a
test is performed with WaveSense Control Solution.
When control solution is applied, the visual ll window
on the WaveSense KeyNote Test Strip turns blue.
Write the discard date on the WaveSense Control
Solution bottle.
Important WaveSense Control Solution
information: [1] Use only WaveSense Control
Solution with your WaveSense KeyNote System. [2]
Always replace the cap on the control solution bottle
immediately after using. [3] Do not add water or any
other liquid to control solution. [4] Control solution
tests should be performed within the system operating
temperature range of 50 °F to 104 °F (10 °C to 40 °C).
[1] Inserting a WaveSense KeyNote Test Strip:
Insert a new WaveSense KeyNote Test Strip into the
meter. The meter will be activated.
[2] Adjusting Code
Number: The meter
will display a test strip
code number. If this is
not the same as the code
number printed on the
in SET Options) MEANING: If the Hyperglycemic Warning
Alarm is set, your glucose test result is higher than the
pre-set limit.
KETONE MESSAGE: Flashing message,
with double beep (if volume is enabled in SET Options)
MEANING: The result of the glucose test is higher than
240 mg/dL. ACTIONS: You should check ketones. Follow
your healthcare professional’s recommendations.
TEMPERATURE MESSAGE: Flashing message, with
double beep (if volume is enabled in SET Options)
MEANING: The test has been performed outside the
operating temperature range. ACTIONS: Move to an area
with an ambient temperature of 50 °F to 104 °F (10 °C
to 40 °C). Wait for the meter and test strips to reach the
new temperature (usually 10-20 minutes) and retest.
MEANING: Glucose test result is lower than 20 mg/dL.
This Lo result may indicate hypoglycemia (low blood
glucose). The Lo result is stored in the memory with
time and date. ACTIONS: If you feel symptoms such
as weakness, sweating, nervousness, headache or
confusion, follow your healthcare professional’s
recommendations. If you get a Lo glucose test result
but have no symptoms of low blood glucose, then retest
with a new WaveSense KeyNote Test Strip. If you still get
a Lo test result, follow your healthcare professional’s
recommendations.
HI MESSAGE: Flashing message, with double
beep (if volume is enabled in SET Options) MEANING:
Glucose test result is above 600 mg/dL. This Hi result
may indicate hyperglycemia (high blood glucose).
The Hi result is stored in the memory with time and
CAUTION: Low or high blood glucose test results
can indicate a potentially serious medical
condition. Follow your healthcare professional’s
recommendations.
The ADA (American Diabetes Association) recommends
the following target ranges for adults with Diabetes:
Pre-Prandial Plasma Glucose 90-130 mg/dL and Post-
Prandial Plasma Glucose < 180 mg/dL. Always consult
your healthcare professional for your recommended
target ranges.
LO MESSAGE: Flashing message, with double
beep (if volume is enabled in SET Options)
LOW BATTERY MESSAGE: Flashing message
MEANING: The battery in your meter is low. ACTIONS:
If the battery symbol appears, the batteries must be
replaced. If the battery symbol appears, the backlight
will be disabled in all modes.
Troubleshooting #1
Troubleshooting Situation #1: Meter does not
enter the TEST Mode after inserting a WaveSense
KeyNote Test Strip.
[1] CAUSE: The batteries have insucient power.
ACTION: Replace the batteries, set time and date,
and test.
date. ACTIONS: If you feel symptoms such as fatigue,
thirst, excessive urination, or blurry vision, follow your
healthcare professional’s recommendations. If you get a
Hi glucose test result but have no symptoms of high blood
glucose, then retest with a new WaveSense KeyNote Test
Strip. If you still get a Hi glucose test result, follow your
healthcare professional’s recommendations. Checking
ketones may be advisable.
HYPOGLYCEMIC WARNING ALARM:
Test result ashes, with double beep (if volume is enabled
in SET Options) MEANING: If the Hypoglycemic Warning
Alarm is set, your glucose test result is lower than the
pre-set limit.
HYPERGLYCEMIC WARNING ALARM:
Test result ashes, with double beep (if volume is enabled
[2] CAUSE: The batteries are installed incorrectly or
there are no batteries in the meter. ACTION: Check that
both batteries are installed correctly, with the positive
(+) sign facing up towards you.
[3] CAUSE: WaveSense KeyNote Test Strip has been
inserted upside down, wrong end in, or incompletely
inserted into the meter. ACTION: Insert the WaveSense
KeyNote Test Strip with the black side up and the
contact bars of the test strip in the meter. Ensure that
the test strip is fully inserted.
[4] CAUSE: Defective meter or defective WaveSense
KeyNote Test Strips. ACTION: Call customer service.
[5] CAUSE: Blood or foreign objects put into the
WaveSense KeyNote Meter strip port. ACTION: Call
customer service.
©2004 – 2008 AgaMatrix, Inc.
All rights reserved.
8100-01821 Rev F
Blood Glucose Monitoring System
OWNER’S GUIDE
Display Messages
INDEX: (THIS SIDE)
1 Important Information
About Your WaveSense
KeyNote™ System
2 Getting Started
3 Symbols
4 Meter Basics
5 Performing a
Control Solution Test
6 How to Test Your
Blood Glucose Level
7 Testing on Your Palm
or Forearm
8 Meter Specications
9 Caring for Your Meter
and Lancing Device
4Meter Basics
METER SYSTEM CHECK
Each time your meter is activated, the meter will
perform a meter system check.
All display segments and the
backlight will briey ash ON.
IMPORTANT: If all the display
segments DO NOT ash ON (each time your
meter is activated), do not use the meter. Call
customer service immediately.
HOW TO ACTIVATE THE METER AND
View Individual Results: [1] When your
meter is deactivated, press any button once. The
display shows the most recent test result with
time and date. [2] Press the LEFT arrow button
repeatedly to scroll thru every test result, starting
from the most recent and ending with the oldest.
View Time-of- Day Averages: [1] When your
meter is deactivated, press any button once. The
display shows the most recent test result with
time and date. [2] Press the RIGHT arrow button
repeatedly to scroll thru your Breakfast, Lunch,
Dinner, and Bedtime Averages.
Enter MENU Mode: [1] When your meter is
deactivated, press and hold any button for 2 seconds
to enter the MENU mode. [2] Press the RIGHT or
LEFT arrow buttons to view the options: MEM (14,
30 and 90 Day Averages and Graphs), SET (meter
settings), and AL1 to AL6 (reminder alarms 1 thru 6).
Enter MEM (Memory) Mode to view 14, 30
and 90 Day Averages and Graphs:[1] Enter
the MENU mode. [2] Press the RIGHT or LEFT
arrow buttons until the MEM symbol is displayed.
[3] When the MEM symbol is displayed, press the
CENTER button.
Enter SET (Settings) Mode: [1] Enter the MENU
mode. [2] Press the RIGHT or LEFT arrow buttons
until the SET symbol is displayed. [3] When the SET
symbol is displayed, press the CENTER button.
HOW TO DEACTIVATE THE METER
To deactivate the meter, press and hold the CENTER
button for 2 seconds. If left inactive for 3 minutes,
the meter will be deactivated automatically.
HOW TO ACCELERATE THROUGH OPTIONS
Hold down the RIGHT or LEFT arrow buttons to
accelerate through options or results.
2Getting Started
Unpack your WaveSense KeyNote System Kit.
Dispose of the packing material properly.
IMPORTANT: To ensure accurate use of meter,
verify the time, date and units of measure.
For step-by-step instructions on setting the time and
date settings, please refer to section 14 “Setting Time
and Date.”
Serial Number:
Manufacturer:
In Vitro Diagnostic Medical Device:
Batch Code:
Consult Instructions For Use:
Do Not Reuse:
Temperature Limitation:
Use By:
Catalogue Number:
SN
DVI
i
2
TOL
3 Symbols
5Performing a Control Solution Test
The WaveSense KeyNote system has 2 levels of control
solution: normal and high. Select the level of control
solution you want to use.
The control solution is used to: [1] Ensure that
your WaveSense KeyNote Meter and Test Strips are
working together properly. [2] Practice testing without
having to use your own blood.
Control solution tests should be performed
when you: [1] First get your WaveSense KeyNote
Meter. [2] Begin using a new vial of WaveSense
KeyNote Test Strips. [3] Suspect that your WaveSense
KeyNote Meter or Test Strips are not working properly.
[4] Think your test results are not accurate. [5] Have
dropped or damaged your meter or exposed your meter
to liquids other than blood samples. [6] Are advised by
your healthcare professional to do so.
Control solution should only be used for 90 days after
rst opening the bottle or until the expiration date
printed on the label, whichever comes rst.
IMPORTANT: Count forward 90 days from the
date you open a new bottle of WaveSense
Control Solution. This is your discard date.
Normal: 80-120 mg/dL
High: 220-320 mg/dL
lancing device is now ready for use.
[2] Calibrating Your WaveSense KeyNote Meter
− Insert a WaveSense KeyNote Test Strip: Insert a
new WaveSense KeyNote Test Strip into the meter.
Make sure you insert the test strip, with the contact bars
facing up, into the strip port. The meter will be activated
automatically.
Note: If you do not start the test within 3 minutes, the
meter deactivates. To reactivate your meter, take out
the unused WaveSense KeyNote Test Strip and reinsert
it into the meter.
− Adjust Code Number: The meter
displays a pre-set test strip code
number for 2 seconds. If this is not the
same as the code number
printed on the test strip
vial, press the LEFT or RIGHT
buttons until the meter
displays the same code
− Pull the Lancet Top
O: Hold the lancet rmly in
place with one hand and use
your other hand to pull o
the lancet top. Do not discard
the lancet top. It should be
used when discarding your
used lancet.
− Replace Lancing Device Cap: Replace
the lancing device cap until it snaps into place. Be careful
not to touch the exposed needle on the lancet.
− Set the Lancing Level: The
WaveSense Lancing Device oers
8 depth settings. Rotate the dial to
the desired setting as shown in the
depth indicator window. Level 1 is the
most shallow; level 8 is the deepest.
If you have never lanced before, it is
recommended that you start at level 3.
− Cock the Handle: Pull the cocking
handle out until it clicks. You may have
already cocked the handle accidentally
while inserting the lancet; this is OK. The
6How to Test Your Blood Glucose Level
The entire
visual ll
window will
turn red.
1
area that you will be testing. Ensure that your palm or
forearm is facing up and held level.
[3] Lance Test Site: Press the tip of the clear cap
against your skin on the palm of your hand (at the base
of the thumb) or forearm. Hold the tip to the test site for
a few seconds before pressing the release button.
[4] Express Blood Drop: After lancing, hold the
lancing device against your skin until a blood droplet
forms. Do not squeeze directly around the lanced area.
Make sure the blood drop is large enough to completely
ll the visual ll window of the test strip. Pull the
lancing device directly o your palm or forearm to
ensure that you do not smear the blood drop. Return to
section 6, step 4 to continue with testing instructions.
Testing glucose levels with blood obtained from the
palm (at the base of the thumb) or forearm may reduce
the pain of testing. The technique for testing on the
palm and forearm is slightly dierent than testing
on the nger. Always discuss changes to your testing
habits with your healthcare professional.
IMPORTANT: When testing on the palm (at the
base of the thumb) or forearm, you may need
to set the lancing device to a deeper setting
or use a larger lancet to obtain enough blood
to perform a test. Consult your healthcare
professional for a recommendation.
[1] Prepare the Lancing Device: Replace the gray
lancing device cap with the clear cap.
[2] Rub Test Site: To increase the blood ow in your
palm (at the base of the thumb) or forearm, rub the
7Testing on Your Palm
or Forearm
When using your meter, avoid getting dirt, dust,
blood, control solution, water or any other liquid into
the strip port and battery compartment. Clean the
outside of the meter or the lancing device using a
cloth dampened with mild detergent or mild soap.
If you wish to clean the lancing device cap only,
remove the cap, wash it in warm water, rinse well,
and dry.
CAUTION: Never immerse the meter or the
body of the lancing device in water or any
other liquid solution.
9
8 Meter Specications
Assay Method: Dynamic Electrochemistry
Maximum Altitude: 10,000 ft
Calibration: Plasma equivalent
Sample: Whole blood, capillary
Sample Size: 0.5 microliters
Average Glucose Test Time: 6 seconds
Measurement Units: mg/dL
Alarms: 6 programmable alarms
Result Range: 20 to 600 mg/dL
Hematocrit: 20% to 60%
Operating Relative Humidity: Up to 90%
Operating Temperature: 50 °F to 104 °F (10 °C
to 40 °C)
Test Strip Storage Temperature: 46 °F to 86 °F
(8 °C to 30 °C)
Memory: 300 blood glucose and control solution
test results with date, time, and averaging (14, 30
and 90 days and time-of-day)
Power Source: Two CR2032, 3 volt, lithium
batteries, replaceable
Automatic Shuto: 3 minutes after last user action
Size: Width 1.6” x Length 2.8” x Height 0.6”
(4.4 cm x 7.7 cm x 1.6 cm)
Weight: 44.1 g (including batteries)
24-Hour
Customer Service:
[phone]
Manufacturer:
AgaMatrix, Inc.
10 Manor Parkway
Salem, NH 03079 USA
This is the visual
ll window. DO
NOT PUT CONTROL
SOLUTION HERE.
Apply control
solution here.
The entire
visual ll
window will
turn blue.
This is the visual ll
window. DO NOT
PUT BLOOD HERE.
Apply blood here.
Important Information About Your WaveSense
KeyNote System
The WaveSense KeyNote System should be
used: [1] For measuring blood glucose levels from fresh
capillary whole blood samples taken from the ngertips,
palms (at the base of the thumb), or forearms. [2] With
WaveSense KeyNote Test Strips and WaveSense Control
Solution only. Use with other unapproved test strips or
control solution will void the manufacturer’s warranty
and will lead to inaccurate results. [3] Outside of the
body (i.e., in vitro diagnostic use only).
Do not use the WaveSense KeyNote System for:
[1] The diagnosis of diabetes. [2] Testing the glucose
levels of neonates. [3] Testing glucose levels of arterial
or venous blood. [4] Testing glucose from sites other
than the ngertip, palm (at the base of
the thumb), or forearm.
Possible test sites: The WaveSense
KeyNote System requires
only 0.5 μL of blood to
perform a glucose test.
For the best results, test
glucose from the tips of
any nger. The palm (at
the base of the thumb) and forearm are
alternate, but less accurate, test sites. Only select soft
and eshy areas to lance. Avoid lancing any bony areas,
obvious veins and moles. Physiological dierences in
circulation between the ngertip, palm (at the base of the
thumb), and forearm may result in dierences in blood
glucose measurements between these sites. Dierences
in glucose concentrations may be observed after eating,
taking insulin medication, or exercise. Changes in blood
glucose may be detected in the ngertips before the palm
(at the base of the thumb) and forearm.
It is recommended that you use a ngertip
sample if: [1] You are testing for hypoglycemia or if
you suer from hypoglycemia unawareness, [2] You are
testing your blood glucose within 2 hours of eating, taking
insulin, diabetes pills, exercise, or [3] Your blood glucose
results obtained from the palm (at the base of the thumb)
or forearm are not consistent with the way you feel.
CAUTION: Please read all the instructions
provided in this owner’s guide and practice the
testing procedures before using the WaveSense
KeyNote Blood Glucose Monitoring System. Blood
glucose monitoring should be done under the
guidance of a healthcare professional.
The following symbols may appear on the
equipment packages or in the documents:
To deactivate the meter, remove the used WaveSense
KeyNote Test Strip. Dispose of used materials properly.
If your control solution test results are out of the range,
repeat the test. If the results from the control solution
tests continue to fall outside that range, do not use the
WaveSense KeyNote System to test your blood glucose.
Call customer service.
IMPORTANT: Out-of-range test results may be
caused by: [1] Expired or defective control solution.
[2] Expired or defective test strip. [3] Error in
performing test. [4] Watered-down control solution.
[5] Code number on WaveSense KeyNote Test Strip
vial not matching code number set in the meter. [6]
Meter malfunction. [7] Control solution test done
outside the operating temperature of 50 °F to 104 °F
(10 °C to 40 °C). [8] Failure to shake the control solution
bottle vigorously. [9] Failure to discard the rst drop of
control solution and to wipe the bottle tip clean.
CAUTION: Results from control solution tests do
not reect your blood glucose level. The control
solution range is a target range for control
solution only. It is not a target range for your
blood glucose level.
Caring for Your Meter
and Lancing Device
In case of emergency, contact your healthcare
professional or emergency response.
Release Button

About the WaveSense KeyNote Meter
(1) Display: Glucose test results, symbols, messages,
and graphs appear here. (2) CENTER Button: Use the
CENTER button to conrm an option or make a selection in
a menu. (3)RIGHT Arrow Button: Use the RIGHT arrow
button to scroll forward through options. (4)Strip Port:
Insert the WaveSense KeyNote Test Strip, with the contact
bars facing up, into the strip port. (5)LEFT Arrow
Button: Use the LEFT arrow button to scroll backward
through options.
About the WaveSense KeyNote Meter Display
Segments
(1)Date and Time: Appears here, including when the
meter is deactivated. (2)Glucose Test Results (3)Low
Battery: Appears when the batteries in your meter are
running low. (4)Temperature Symbol: Appears when
the meter is outside its operating temperature range of 50
a combination of high glucose and other medical
conditions. [2] If this error code persists on retesting,
consult your healthcare professional.
Error 6: The test strip has taken too long to
generate a signal.
[1] This may be caused by a combination of cold
operating temperature and high hematocrit levels. Retest
in a warmer location. [2] If this error code persists on
retesting, consult your healthcare professional.
Error 7 with Battery Icon:
Replace batteries immediately before testing.
Error 7:
Meter problems have occurred that are beyond your
control. Contact customer service for assistance.
Press the RIGHT or LEFT arrow buttons to view your 30 day
trend graph.
You can move from the 30
day trend graph to the 30
day numerical average by
pressing the RIGHT or LEFT
arrow buttons.
− View 90 Day Averages and Graphs:
Press the CENTER button to view your 90 day numerical
average. Press the RIGHT or LEFT arrow buttons to view
your 90 day trend graph.
You can move from the 90
day trend graph to the 90
day numerical average by
pressing the RIGHT or LEFT
arrow buttons.
− View 14, 30 and 90 Day Average
Comparison Graph: Press CENTER button
to view your 14, 30 and 90 day average
comparison graph. The display shows an
overview with three trend bars comparing
the 14, 30 and 90 days averages.
[1] Enter MENU Mode: When your meter is
deactivated, press and hold any button for 2 seconds
to enter the MENU mode.
[2] Enter SET Option: The MEM
symbol will appear. Press the RIGHT
arrow button until the SET symbol is
displayed. Press the CENTER button.
[3] Setting Meter Volume: There
are three beep volume options. The default setting
is “high.” Select the preferred volume setting with
the RIGHT or LEFT arrow buttons. Your selection
will be highlighted by the blinking of the symbol.
Press the CENTER button to conrm
your selection. Continue to set the
MENU Mode Backlight option.
Note: The meter will always produce a beeping
sound after you have applied blood or control
solution to a test strip. This sound lets you know
when to take your blood sample or control solution
away from the test strip. You will hear this sound if
the volume is set to ON or OFF in the SET Options.
Error 3: The meter has detected that the test
strip is in poor condition.
[1] The test strip may have been improperly stored
(e.g. hot, humid conditions) or may be expired. [2]
The test strip may have been mishandled by vigorous
bending or shaking. [3] Parts of the test strip may have
become covered in grease, oil or lotion. [4] The strip port
connector may be dirty.
Error 4: Unusual test strip problems have
occurred that may be related to extreme conditions.
[1] Retest where it is closer to a room temperature of
70 °F to 75 °F (21 °C to 24 °C).
Error 5: The meter was unable to produce a
reliable result.
[1] This may be caused by a non-blood sample or
Error 1: Problems have occurred that are
related to test strip use.
[1] If this message appears the moment the test strip is
inserted, the test strip may be wet or damaged. [2] If the
message appears during a test, the test strip may have
been removed too early. [3] If this message appears after
the last progress bar instead of a result, it may indicate
that you applied more blood after testing began.
Error 2: The meter has detected an irregularity
with the sample.
[1] The test strip may be partially lled; you should check
the window of the test strip to conrm that it is full. [2] The
sample may not be blood or control solution. [3] You may
have entered the wrong calibration code.
Press the RIGHT arrow button. The
display now shows your lunch average.
Press the RIGHT arrow button. The
display now shows your dinner
average.
Press the RIGHT arrow button. The dis-
play now shows your bedtime average.
Note: To return to the most recent test
result, press CENTER button.
[2] Viewing Individual Results
Press and release the CENTER button.
The display will show the most recent
glucose test result with the time and
date. Use the LEFT arrow button to
view every test result, starting from
the most recent and ending with the oldest.
Note: At any point, press CENTER button to return to
the most recent test result.
Set the day (ashing) with the RIGHT or LEFT arrow
buttons. Press the CENTER button to conrm and
move on the year setting.
Set the year (ashing) with the RIGHT or LEFT arrow
buttons. Press the CENTER button to conrm and
continue on to set the Hypo Limit.
This section covers the steps on how to view
your:
– Most Recent Glucose Test Result
– 300 Past Glucose Test Results, with time and date
– Breakfast, Lunch, Dinner and Bedtime Averages
The WaveSense KeyNote Meter calculates averages
of all the test results during breakfast, lunch, dinner
and bedtime. Control solution, Hi and Lo test results,
out-of-temperature-range results, and results without
a valid date / time are not included in the averages.
Averages are composed of results only within the
last 14 days. Breakfast averages include glucose
measurements between 4:00 AM and 10:00 AM, lunch
averages are between 10:00 AM and 4:00 PM, dinner
averages are between 4:00 PM and 10:00 PM, and
bedtime averages are between 10:00 PM and 4:00 AM.
[1] Viewing Time-of-Day Averages
Press any button once when the meter
is deactivated. The display shows the
most recent glucose test result with
the time and date. Press the RIGHT
arrow button. The display now
shows your breakfast average.
[2] Enter Memory Option
When the MEM symbol appears,
press the CENTER button to enter the
Memory option.
Note: Use the RIGHT or LEFT arrow buttons to scroll
through the MENU Mode options.
[3] Viewing MEMORY Test Results
− View 14 Day Averages and Graphs: The display
shows your 14 day numerical average. Press the RIGHT or
LEFT arrow buttons to view your 14 day trend graph.
You can move from the 14
day trend graph to the 14
day numerical average by
pressing the RIGHT or LEFT
arrow buttons.
− View 30 Day Averages and Graphs: Press the
CENTER button to view your 30 day numerical average.
This section covers the steps on how to view
your:
– 14 Day Numerical Average and Trend Graph
– 30 Day Numerical Average and Trend Graph
– 90 Day Numerical Average and Trend Graph
– 14, 30 and 90 Day Averages Comparison Graph
The WaveSense KeyNote Meter calculates the averages
from the last 14, 30 and 90 days, starting from the
current time and date shown on the meter. Control
solution, Hi and Lo test results, out-of-temperature-
range results, and results without a valid time / date
are not included in the averages.
IMPORTANT: Results, averages, and graphs
stored in memory should only be used as a
reference. Do not make treatment decisions
based solely on stored results, averages,
and graphs. Consult with your healthcare
professional regarding treatment options.
[1] Enter MENU Mode
Press and hold any button for 2 seconds to enter the
MENU mode.
30
90
30
90
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12 View 14, 30 and 90 Day Averages and Graphs
mg /dL
The number of glucose test results
saved (within the time period) is
displayed in the top right corner.
14
mg /dL
mg /dL
mg /dL
11 Time-of-Day Averages and Individual Results
Error Messages
The WaveSense KeyNote Blood Glucose Monitoring
System has been designed to work accurately under
most usual conditions. On rare occasions, the meter will
display an error message instead of a glucose result. The
WaveSense KeyNote system is able to detect specic
problems which may allow you to determine the cause of
the error without wasting valuable test strips. When you
are presented with an error message, check for common
problems that may explain the source of the error.
CAUTION: In certain cases, the meter may return
an error code or provide an inaccurate result if it is
being used near electrical equipment, like a power
generator or a computer monitor.
Troubleshooting #2
[4] Setting Your Hyperglycemic Warning Alarm:
WARNING: Your healthcare professional should
recommend what your hyperglycemic limit is.
The Hyperglycemic Warning Alarm alerts you when your
glucose test results are above the hyperglycemic limit that
you have set. The meter is pre-set to a hyperglycemic limit of
240 mg/dL. Always consult your healthcare professional for
your recommended target ranges. When your glucose test
results are above your set hyperglycemic limit, the date, time
and result will ash on the display.
Set the Hyperglycemic Limit ON or OFF
with the RIGHT or LEFT arrow buttons.
Your selection will be highlighted by the
blinking of the symbol. Press CENTER
button to conrm your selection.
Set the Hyperglycemic Limit (ashing)
with the RIGHT or LEFT arrow buttons.
Press CENTER button to conrm. This
will bring you back to MENU Mode at
the SET options.
ready to set the meter’s time.
Select a 12 or 24 hour clock format
with the RIGHT or LEFT arrow buttons.
The 12 hour clock display option is indicated by a 12H.
The 24 hour clock display option is indicated by a 24H.
Your selection will be highlighted by the blinking of
the symbol.
Press the CENTER button to conrm your selection and
move on to the hour setting.
Set the hour (ashing) with the RIGHT or LEFT arrow
buttons. Press the CENTER button to conrm and
continue on to set the minute.
Set the minute (ashing) with the RIGHT or LEFT arrow
buttons. Press the CENTER button to conrm and
continue on to set the date.
[4] Setting Date: Set the month (ashing) with
the RIGHT or LEFT arrow buttons. Press the CENTER
button to conrm and continue on to the day
setting.
14 Setting Time and Date
[4] Setting Backlight Option: You can enable
or disable the backlight. The default setting for
the backlight is enabled. The changed status of the
backlight will be activated immediately.
Select the preferred setting with the
RIGHT or LEFT arrow buttons. Press the
CENTER button to conrm and continue
on to set the Time Format and Time.
Note: Disabling the backlight in the SET menu also
disables backlight for alarms.
13 Setting Meter Volume
and Backlight
16 Setting Alarms
There are 6 alarms you can set to remind you
when to test your glucose levels.
When alarms are activated: [1] If an
alarm is set and the WaveSense KeyNote Meter
is deactivated, the alarm will activate the meter.
“AL1” thru “AL6” (depending which alarm is set)
is displayed. The display backlight ashes, and
the meter will beep repeatedly for 15 seconds.
[2] You can turn the alarm OFF by pressing any
button. [3] The alarms will not appear during
Menu and Test Modes. If an alarm is set to sound
or ash while using these modes, it will appear
after the meter is deactivated.
CAUTION: Follow your healthcare
professional’s recommendations on when
and how often to test your glucose.
[1] Enter MENU Mode: When your meter is
deactivated, press and hold any button for 2
seconds to enter the MENU mode.
[2] Enter Alarm Option: The MEM symbol
appears. Press the RIGHT or LEFT arrow buttons
:PM
:PM
until the alarm you want to set is
displayed (AL1 to AL6). If this is your
rst time setting an alarm, use AL1.
Press CENTER to select an alarm
to set.
[3] Turning Alarms ON or OFF: Press the
RIGHT or LEFT arrow buttons to enable (ON)
or disable (OFF) the alarm. The
default setting is OFF. Conrm
your selection by pressing CENTER
button. Your selections will be
highlighted by a blinking symbol.
[4] Setting Alarm Times: You
can now set the time. First, set
the ashing numbers (hour) with
the RIGHT or LEFT arrow buttons.
Accelerated change is possible by
holding down the arrow buttons.
Press CENTER to conrm and to
move on to set the minute.
Set (minute) with the RIGHT or
LEFT arrow buttons. Press the
CENTER button to conrm the
alarm time and to move on to set
the alarm volume.
[5] Setting Alarm Volumes: There are
three volume options. A silent alarm will only
ash the meter’s screen. The
default setting is “high”. Select
your preferred setting with the
RIGHT or LEFT arrow buttons.
Conrm by pressing the CENTER
button. This will bring you back
to MENU Mode.
Note: The volume of an alarm will be aected by
the meter’s volume setting, which can be changed
in the meter’s settings (SET) option. If your meter is
set to silent mode, then the alarm will not sound,
regardless of the individual alarm setting. Also, if
your meter is set to low volume mode, then an alarm
set for high volume will default to low volume mode.
[6] Setting Multiple Alarms: To set other
alarms, press the RIGHT or LEFT arrow buttons
until the alarm you want to set (AL1 to AL6)
is displayed. Follow the previous steps in this
section 16, “Setting Alarms.”
:PM
:PM
[1] Enter MENU Mode: When your meter is
deactivated, press and hold any button for 2 seconds to
enter the MENU mode.
[2] Enter SET Option: The MEM
symbol will appear. Press the RIGHT
arrow button until the SET symbol is
displayed. Press the CENTER button.
[3] Setting Time: Press CENTER repeatedly until
you see a screen with the message 12H or 24H, you are
Hour: :PM
Year:
mg /dL
mg /dL
[3] Setting Your Hypoglycemic Warning
Alarm: Press CENTER repeatedly until you see the HYPO
symbol in the top right corner of the screen. You are
ready to set the Hypoglycemic Warning Alarm.
WARNING: Your healthcare professional should
recommend what your hypoglycemic limit is.
The Hypoglycemic Warning Alarm alerts you when your
glucose test results are below the hypoglycemic limit that
you have set. The meter is pre-set to a hypoglycemic limit
of 70 mg/dL. Always consult your healthcare professional
for your recommended target ranges. When your glucose
test results are below your set hypoglycemic limit, the date,
time and result will ash on the display.
Set the Hypoglycemic Limit ON or OFF
with the RIGHT or LEFT arrow buttons.
Your selection will be highlighted
by the blinking of the symbol. Press
the CENTER button to conrm your
selection.
Set the Hypoglycemic Limit (ashing)
with the RIGHT or LEFT arrow buttons.
Press CENTER button to conrm and
continue on to set the Hyper Limit.
mg /dL
mg /dL
15 Setting Hypoglycemic
and Hyperglycemic
Warning Alarms
Minute: :PM
Month:
Day:
CAUTION: When the battery symbol appears, you
should replace the batteries immediately. Only
use CR2032 batteries.
Your WaveSense KeyNote Meter comes with two pre-
installed, CR2032, 3 volt, lithium batteries. If your batteries
run low, the battery symbol ashes until you change the
batteries. The backlight is disabled in all modes when the
battery symbol is on. When changing batteries the current
time and date settings will be reset. The time and date will
automatically be set to 01-01 12:00. Correct time and date
settings are needed to get correct averages. Removing the
batteries does not aect the meter’s memory or previously
stored user settings, such as those set in SET Options (e.g.
calibration code, alarms, etc.). If a battery is installed
incorrectly it will damage the other battery in the meter. If
this happens discard both batteries.
Replacing the Batteries
[1] Open Battery Door: Make
sure the meter is deactivated. Turn
the meter so you are looking at the
battery door. Press the battery door
clip to the right to open. Remove the
battery door. Be careful not to misplace the battery door.
[2] Remove and Install 1st Battery: To remove
the used battery, use a non-metallic tool at point A to
pop out the battery. Install the
new battery with the positive
(+) sign facing up towards you.
[3] Remove and Install
2nd Battery: Repeat previous step
for the 2nd battery.
[4] Close Battery Door: Angle
the battery door back onto the
meter. Swing down and press the
door until it snaps gently into place.
Make sure that the battery door is
completely closed before using.
17 Batteries
Used: New:
Troubleshooting Situation #2: The glucose test
sequence does not start after applying the blood sample.
[1] CAUSE: Defective test strip. ACTION: Repeat the test
with a new WaveSense KeyNote Test Strip. If this does not
work, call customer service.
[2] CAUSE: Sample applied after meter times out
and deactivates. ACTION: Repeat the test using a new
WaveSense KeyNote Test Strip. Wait until you see the
blood and test strip symbols on the display screen before
you apply the blood sample.
[3] CAUSE: Defective meter. ACTION: Call customer
service.
high volume. (12)Low Volume: small bell indicates
low volume. (13) Volume OFF: small bell with a
line across it indicates mute. (14)14, 30 and 90
Day Indicators: The appropriate number of days will
appear when viewing graphical averages. (15) 1,2,3
Countdown: The 1,2 and 3 symbols will appear during
a test. (16)Graphing Area: Areas of the dot matrix
will appear during a test and when displaying graphs.
About the WaveSense Lancing System
(1)Cocking Handle: Cocks the device so it is ready
to lance. (2)Depth Adjustment Dial: Adjusts
how deep the lancet will lance the skin. (3)Depth
Indicator Window: Displays the depth setting of the
lancing device. (4)Release Button: Fires the lancet.
(5)Lancet: Lances the skin to produce a drop of
blood. (6) Lancet Cap: Covers the lancet for safety.
(7)Lancing Device Cap: Covers the lancet when in
lancing device. Remove after inserting into the lancet
holder cup. (8) Alternate Site Testing Cap: Used
for obtaining a blood sample on the palm (at the base
of the thumb) or forearm.
size, 0.5 μL of blood, about the size of a pinhead.
CAUTION: Discard used test strips properly.
IMPORTANT: Use WaveSense KeyNote Test Strips
only once. Only use WaveSense KeyNote Test Strips
with the WaveSense KeyNote System.
Important Test Strip Information:
[1] Store the WaveSense KeyNote Test Strip vial in a
cool, dry place at 46 °F to 86 °F (8 °C to 30 °C). [2] Use
WaveSense KeyNote Test Strips only within the system
operating temperature range of 50 °F to 104 °F (10 °C to
40 °C ). [3] Keep away from direct sunlight and heat.
[4] Store your WaveSense KeyNote Test Strips in their
original vial only; never store them in another vial, any
other container or outside the vial. [5] After removing a
WaveSense KeyNote Test Strip from the vial, immediately
close the vial cap tightly. [6] With clean, dry hands you
may gently handle the WaveSense KeyNote Test Strip
when removing it from the vial or inserting it into the
meter. [7] Do not use WaveSense KeyNote Test Strips
beyond the expiration date or 90 days after rst opening
the vial. This may cause inaccurate results. Write the
discard date (90 days from the rst opening) on the
test strip vial. [8] Do not bend, cut or alter WaveSense
°F to 104 °F (10 °C to 40 °C ). (5)Code Symbol: Appears
when displaying the code number of the test strip. (6)
Ketone Symbol: Appears when your glucose test results
are higher than 240 mg/dL. (7)Control Solution
Symbol: Appears after you have performed a control
solution test. (8)Units of Measurement: Results will
be displayed in mg/dL.
(9)Apply Sample to Test Strip: The test strip symbol
and ashing droplet symbol will signal you to apply
sample to the test strip. (10)Sample Entering Test
Strip: The three droplet symbols will appear within the
test strip symbol when blood or control solution enters
the test strip. (11)High Volume: large bell indicates
10 About the WaveSense KeyNote System
Your WaveSense KeyNote System includes:
- WaveSense KeyNote Blood Glucose Meter
- Two Pre-installed CR2032, 3 volt, Lithium Batteries
- Lancing Device with Cap
- Clear AST Lancing Device Cap
- 10 Sterile Lancets
- Compact Carrying Case
- Control Solution
- Owner’s Guide
About the WaveSense KeyNote Test Strip:
With your WaveSense KeyNote System, you can test
your blood glucose on your ngertips, palms (at the
base of the thumb) and forearms. Testing with the
WaveSense KeyNote System requires a small sample
1
3
5
2
4
Ketone control
code
AM
:PM
mmgl/dL 8
3
4
5
7
1
6
2
1
2
3
30
90
14
11
14
10
9
16 15
12
13
3
1
2
7
5
4
6
8
KeyNote Test Strips. [9] Apply only fresh capillary blood
or control solution to the sample area of the WaveSense
KeyNote Test Strip.
Contact Bars: Insert
this end, facing up, into
the meter’s strip port.
18 Important Health-
Related Information
results. If you believe you are suering from severe
dehydration, consult your healthcare professional
immediately. [2] The ADA (American Diabetes
Association) recommends the following target ranges
for adults with Diabetes: Pre-Prandial Plasma Glucose
90-130 mg/dL and Post-Prandial Plasma Glucose <
180 mg/dL. Always consult your healthcare profes-
sional for your recommended target ranges. [3]
Results below 70 mg/dL may mean low blood glucose
levels (hypoglycemia). [4] Results over 240 mg/dL
may mean high blood glucose levels (hyperglycemia).
Checking ketones may be advisable. [5] If you get re-
sults below 70 mg/dL or above 240 mg/dL and do not
have symptoms of hypoglycemia or hyperglycemia,
repeat the test. If you have symptoms, or continue to
get results that fall below 70 mg/dL or rise above 240
mg/dL, follow your healthcare professional’s recom-
mendations. [6] If you are experiencing symptoms
that are not consistent with your blood glucose test
and you have followed all instructions described in
the WaveSense KeyNote Owner’s Guide, follow your
healthcare professional’s recommendations. [7]
Patients undergoing oxygen therapy may receive
inaccurate results. [8] Always follow your healthcare
professional’s recommendations.
[1] Enter MENU Mode: When your meter is
deactivated, press and hold any button for 2 seconds to
enter the MENU mode.
[2] Enter SET Option: The MEM symbol will appear.
Press the RIGHT arrow button until the SET symbol is
displayed. Press the CENTER button.
INDEX: (THIS SIDE)
10 About the WaveSense
KeyNote System
11 Time-of-Day Averages and
Individual Results
12 View 14, 30 and 90 Day
Averages and Graphs
13 Setting Meter Volume
and Backlight
14 Setting Time and Date
15 Setting Hypoglycemic and
Hyperglycemic Warning
Alarms
16 Setting Alarms
17 Batteries
18 Important Health-Related
Information
Visual Fill Window:
The window will turn
red when enough blood
has been applied or
blue when enough
control solution has
been applied.
Sample Area: Apply
blood or control solution
to the edge of the test
strip here.
One dot represents 50 mg/dL.
One dot represents 20 mg/dL.
:PM
Please Read the Following: [1] Severe dehydra-
tion and excessive water loss may yield inaccurate
A
A
Meter Firmware ©2004-2008 AgaMatrix, Inc.
US and International Patents Pending. All rights
reserved. All trademarks and copyrights are the
property of their respective owners.
24-Hour
Customer Service:
[phone]
In case of emergency, contact your healthcare
professional or emergency response.